MEDICLAS Study (Metabolic Effects of Different Classes of AntiretroviralS)

NCT00122226 | Unknown Phase 4

• 1 other identifier: protocol 02-72
• Study Type: interventional
• Target: 50
• Locations: 4 countries
• Sites: 13

Brief Summary

This is a randomized prospective study into metabolic adverse events during different types of initial antiretroviral therapy in HIV-1-infected men.

Conditions

HIV Infections; HIV-Associated Lipodystrophy Syndrome

Keywords

HIV; HIV-associated lipodystrophy syndrome

Outcome Measures

Primary Outcomes (5)

• insulin resistance (3, 12, 24, 36 months)

• microvascular function (3, 12, 24, 36 months)

• lipid profile (3, 12, 24, 36 months)

• body composition (3, 12, 24, 36 months)

• macrovascular function (12, 24, 36 months)

Secondary Outcomes (4)

• mitochondrial DNA in PBMC and fatty tissue (12, 24, 36 months)

• gene expression, markers of mitochondrial toxicity, inflammation, apoptosis, fat cell differentiation in fatty tissue (12, 24, 36 months)

• bone mineral density (12, 24, 36 months)

• natural killer cells (3, 12, 24 months)

Interventions

Lopinavir/ritonavir + zidovudine + lamivudine DRUG

Lopinavir/ritonavir + nevirapine DRUG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male
• Age between 18 and 70 years.
• No prior use of antiretroviral therapy
• Indication for antiretroviral treatment according to common standards

You may not qualify if:

• Female sex
• Body mass index (kg/m2) \> 35.
• Known history of diabetes mellitus or hyperlipidemia
• Use of the following medication: systemic corticosteroids, thiazide diuretics, calcium-entry blockers, angiotensin-converting inhibitors, nitrates
• Use of nandrolone or testosterone
• Any disorder or condition which can be expected to lead to lessened compliance with the study protocol.

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead
• Abbott: collaborator
• Boehringer Ingelheim: collaborator

Study Sites (13)

Helsinki University Central Hospital

Helsinki, Finland

Location

Academic Medical Center

Amsterdam, Netherlands

Location

Medisch Centrum Jan van Goyen

Amsterdam, Netherlands

Location

Onze Lieve Vrouwe Gasthuis, location Oosterpark

Amsterdam, Netherlands

Location

Onze Lieve Vrouwe Gasthuis, location Prinsengracht

Amsterdam, Netherlands

Location

Slotervaart ziekenhuis

Amsterdam, Netherlands

Location

VUMC Free University Medical Center

Amsterdam, Netherlands

Location

Kennemer Gasthuis, location Elisabeth

Haarlem, Netherlands

Location

Leids Universitair Medisch Centrum

Leiden, Netherlands

Location

Erasmus Universitair Medisch Centrum

Rotterdam, Netherlands

Location

Ziekenhuis Leyenburg

The Hague, Netherlands

Location

Hospital Clinic

Barcelona, Spain

Location

Royal Free Hospital

London, United Kingdom

Location

Related Publications (4)

• van Vonderen MG, Blumer RM, Hassink EA, Sutinen J, Ackermans MT, van Agtmael MA, Yki-Jarvinen H, Danner SA, Serlie MJ, Sauerwein HP, Reiss P. Insulin sensitivity in multiple pathways is differently affected during zidovudine/lamivudine-containing compared with NRTI-sparing combination antiretroviral therapy. J Acquir Immune Defic Syndr. 2010 Feb;53(2):186-93. doi: 10.1097/QAI.0b013e3181c190f4.

  PMID: 19898246 DERIVED

• van Vonderen MG, van Agtmael MA, Hassink EA, Milinkovic A, Brinkman K, Geerlings SE, Ristola M, van Eeden A, Danner SA, Reiss P; MEDICLAS study group. Zidovudine/lamivudine for HIV-1 infection contributes to limb fat loss. PLoS One. 2009 May 21;4(5):e5647. doi: 10.1371/journal.pone.0005647.

  PMID: 19479079 DERIVED

• van Vonderen MG, Lips P, van Agtmael MA, Hassink EA, Brinkman K, Geerlings SE, Sutinen J, Ristola M, Danner SA, Reiss P. First line zidovudine/lamivudine/lopinavir/ritonavir leads to greater bone loss compared to nevirapine/lopinavir/ritonavir. AIDS. 2009 Jul 17;23(11):1367-76. doi: 10.1097/QAD.0b013e32832c4947.

  PMID: 19424051 DERIVED

• van Vonderen MG, Hassink EA, van Agtmael MA, Stehouwer CD, Danner SA, Reiss P, Smulders Y. Increase in carotid artery intima-media thickness and arterial stiffness but improvement in several markers of endothelial function after initiation of antiretroviral therapy. J Infect Dis. 2009 Apr 15;199(8):1186-94. doi: 10.1086/597475.

  PMID: 19275490 DERIVED

MeSH Terms

Conditions

HIV Infections; HIV-Associated Lipodystrophy Syndrome

Interventions

Lopinavir; Ritonavir; Zidovudine; Lamivudine; Nevirapine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Lipodystrophy; Skin Diseases, Metabolic; Skin Diseases; Skin and Connective Tissue Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Thymidine; Pyrimidine Nucleosides; Dideoxynucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Zalcitabine; Deoxycytidine; Cytidine; Pyridines

Study Officials

• S. A. Danner, MD, PhD

  Free University Medical Center

  PRINCIPAL INVESTIGATOR

• P. Reiss, MD, PhD

  Academic Medical Center, National AIDS Therapy Evaluation Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 14, 2005
• First Posted: July 21, 2005
• Study Start: January 1, 2003
• Study Completion: July 1, 2008
• Last Updated: April 25, 2006

Record last verified: 2005-07

Locations

ES (1); FI (1); NL (10); GB (1)